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FDA Pipeline Preview, February 2008

Article

FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120

Approvable designations

Complete response letter

Nonapprovable designations

Fast-track designations

Priority review

Orphan drug designations

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